Euro Roundup: MDCG overhauls guidance on significant MDR changes

The Medical Device Coordination Group (MDCG) has rewritten and expanded its guidance on what constitutes a “significant change” to a legacy medical device under the transitional provisions of the new European Union regulations.

Products with certificates issued under the old EU directives can stay on the market during the transition to the new Medical Device Regulations (MDR), provided they do not undergo any significant changes. MDCG met the call for guidance on what changes EU authorities would deem significant in March 2020. MDCG has updated the guidance now that the transition period has been extended.
The new text “takes into account the experience gained with the application of the original version so far,” MDCG wrote, and aligns the document with the equivalent in vitro diagnostic guidance that the coordination group published a year ago.

The heart of the new guidance is a section on assessing whether changes are “significant changes in the design or intended purpose.” It is broken up into three sections — general, changes not concerning the design or intended purpose, and changes in the design or intended purpose — and further split into subsections. MDCG has used the update to clarify foundational aspects of the EU approach to significant changes.

“The manufacturer is responsible for providing evidence and justification that a change does not affect the design or intended purpose, or, in case the change affects design or intended purpose of the device, that it is non-significant, which should be assessed case-by-case. The outcome of the assessment should be documented and made available to a competent authority when requested,” MDCG wrote.

MDCG’s section on changes not concerning the design or intended purpose is entirely new and notes that changes in the manufacturer’s organization or manufacturing process “should generally not be considered changes in the design or intended purpose.” Equally, tweaks to the quality management system “such as changes in the monitoring and control of production and operations environment” do not generally affect the design or intended purpose, according to MDCG.

The coordination group has expanded the section on changes in the design or intended purpose, in part to explain the revised flow charts in the annex that walk readers through the process of determining if a change is significant. Each chart covers a different type of change, such as to the intended purpose or the software. MDCG has created accompanying text to expand on how manufacturers should reach conclusions.

MDCG Guidance

MHRA creates guide to reporting adverse Software as a Medical Device incidents

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on how to report adverse incidents involving Software as a Medical Device (SaMD) under the vigilance system.

MHRA applies the same three reporting criteria to physical and software-based medical devices, but the differences between the two types of products and the kind of incidents they are likely to cause have led the regulatory agency to create specific guidance for SaMD. Indirect harms, such as misdiagnosis because of imprecise results, are more likely to arise from the use of software than direct harm.

The guidance goes on to provide examples of SaMD incidents that may require reporting. MHRA has grouped the examples into categories, such as performance issues, decision support software resulting in harm and human-device interface problems.

Examples of performance issues that may require reporting include the failure of a tool to alert a healthcare professional when the user’s mental health status reaches a predetermined clinical threshold, and accelerated MRI software that degrades the appearance of anatomical and pathological structures leading to an incorrect, delayed or missed diagnosis.

Reportable human-device interface problems can occur when the keyboard or touch screen prevents the accurate input of data, or the failure to account for color blindness leads to a missed warning in the interface.

MHRA expects manufacturers to report such problems, as per the general guidance on medical device vigilance. The agency is advising manufacturers “to monitor customer feedback on social media channels and UK app stores and report where appropriate.”

MHRA Guidance

EFPIA warns product liability changes ‘may undermine Europe’s competitiveness”

Pharma trade group EFPIA has joined with other bodies representing a range of industries to warn that the EU’s planned revisions to the product liability directive may cause “a rise in litigation and speculative claims.”

The original Product Liability Directive dates to 1985 and advances such as artificial intelligence and Internet of Things devices have raised questions it was not designed to address. According to EFPIA, MedTech Europe and nine other trade groups, revisions to the directive to address those questions have expanded to alter “long-standing and balanced rules that function well.”

“We fear that suboptimal final rules will have unwanted negative implications for future case law and will not instill confidence in, or incentivise, manufacturing in Europe. This contradicts the commitments made by the Council of the EU to ensure that a competitiveness check is performed for every EU initiative,” the trade groups wrote.

The letter warns the changes will facilitate “unregulated, profit-motivated, third-party claims taking advantage of consumer claims to launch class actions” and introduce a definition of “damage” that will lead to misalignment with EU and national law because it covers “psychological harm and data loss.”<

EFPIA and its co-authors are also concerned that the revised directive will reverse the long-standing position that “the claimant must prove the damage, the defect and the causal link between the two.” Instead, the proposals require “defendants to prove a negative.”

Joint Letter

Team-NB updates position paper on hybrid audits to further harmonization agenda

Notified body trade group Team-NB has updated its position paper on hybrid audits to support harmonization and in response to feedback on the version released last year.

In revising the paper, Team-NB has changed its list of benefits of hybrid audits, deleting lines about how they increase effectiveness for certain activities and boost the availability of subject matter experts, and adding a line about how they “promote inclusivity.”

Team-NB also added a line to a section on audit team qualification. The section now states that the site auditor performing the on-site part of a hybrid audit should “have sufficient knowledge as site auditor on the device and the device related technologies as appropriate to the audited activities.”

The other notable change is the addition of the statement that “any existing site should be audited on-site at least once during the certification period, in order to confirm its existence and verify what activities are performed.”

Position Paper

Euro Roundup: MDCG overhauls guidance on significant MDR changes

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